Manufacturing Senior Training Coordinator

Role Summary

Manufacturing Senior Training Coordinator responsible for overseeing the assignment and delivery of manufacturing training curriculums for new employees, providing hands-on instruction, coordinating training events with supervisors, assessing training effectiveness, and maintaining qualification status. Collaborates with quality and training groups to continuously improve materials, performs personnel qualifications on critical operations, and supports quality systems through CAPAs and Change Controls. Reports to Manufacturing Manager.

Responsibilities

• Assign appropriate curriculum to new employees and provide a detailed overview of the manufacturing portion of the training program
• Collaborate with manufacturing supervisors to schedule training events for manufacturing personnel
• Provide hands-on training of manufacturing staff
• Assess training effectiveness and work with training and quality groups to continuously improve training materials and curriculum
• Perform qualification of manufacturing personnel on critical operations including aseptic technique and swab sampling
• Provide detailed qualification status via training reports and identify gaps or opportunities
• Support quality systems and implement action items stemming from CAPAs and Change Controls
• Present the training process during audits and inspections
• Wear appropriate personal protective equipment and gain entry to biotechnology/pharmaceutical manufacturing areas
• Lift, pull, or push equipment up to 25-50 lbs
• Stand for 6 hours in a production suite
• Climb ladders and work platforms; stoop or bend to check or troubleshoot equipment operations
• Work around chemicals (alcohols, acids, bases)

Qualifications

• Requires a high school diploma and 6+ years related industry experience or an Associate's Degree in Life Sciences/Engineering with 5 years of GMP Manufacturing Experience
• Biotech Certificate and prior leadership experience preferred
• Experience with SAP, LIMS and TrackWise; lean operating principles a plus
• Requires 5+ years of GMP Training experience; experience coaching other Training Coordinators required
• Operational knowledge of upstream or downstream manufacturing including CIP and SIP; familiarity with general production equipment
• Knowledge of cGMPs and applicable agency regulations (FDA, EMA) to ensure inspection readiness

Skills

• Training program design and delivery
• Qualification assessment and reporting
• Quality systems and CAPA/Change Control coordination
• Audits and regulatory readiness
• Manufacturing operations knowledge (CIP/SIP, equipment)
• Cross-functional collaboration
• Mentoring and leadership

Education

• High school diploma required; associate degree or biotech certificate preferred